A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis

• Status: Not yet recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AmMax Bio, Inc.

Criteria

Inclusion Criteria:

1. Subjects ≥40 years old.

2. History of confirmed diagnosis of IPF

3. Chest HRCT at Screening

4. Subjects who are either:

• Not being treated with approved IPF therapies (i.e., nintedanib or pirfenidone) or

• Being treated with approved IPF therapies (i.e., nintedanib or pirfenidone)

5. Has FVC ≥45% predicted of normal AND DLCO ≥25% and ≤90% predicted

6. Has a FEV1/FVC ratio (Tiffeneau-Pinelli Index) ≥ 0.70

7. Has adequate hematologic, hepatic, and renal function

Exclusion Criteria:

1. Prior investigational drug use within 30 days or 5 half-lives

2. Presence of emphysema exceeding the extent of fibrosis

3. Active or anticipated need for lung transplant

4. Treatment with prednisone

5. Active cancer

6. Active or chronic infection with HCV, HBV, or HIV

7. Known active tuberculosis

8. History of or current immunosuppressive condition

9. IPF exacerbation within 12 weeks

10. Lower respiratory-tract infection requiring antibiotic therapy

11. Smoking

12. Other forms of interstitial lung disease

13. History of lung volume reduction surgery or lung transplant

14. Contraindications for forced expiratory maneuvers during spirometry

15. Unstable cardiac or pulmonary disease (other than IPF)

16. Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)

17. History of drug or alcohol abuse -